Please wait while the formulary information is being retrieved.
Drug overview for GONAL-F RFF (follitropin alfa, recomb):
Generic name: FOLLITROPIN ALFA, RECOMB (FOL-i-TROE-pin AL-fa)
Drug class: Follicle-Stimulating Hormone (FSH)
Therapeutic class: Endocrine
Follitropin alfa and follitropin beta are recombinant human follicle stimulating hormones (hFSH) with 2 glycoprotein subunits (alpha and beta) that are identical to those of hFSH.
No enhanced Uses information available for this drug.
Generic name: FOLLITROPIN ALFA, RECOMB (FOL-i-TROE-pin AL-fa)
Drug class: Follicle-Stimulating Hormone (FSH)
Therapeutic class: Endocrine
Follitropin alfa and follitropin beta are recombinant human follicle stimulating hormones (hFSH) with 2 glycoprotein subunits (alpha and beta) that are identical to those of hFSH.
No enhanced Uses information available for this drug.
DRUG IMAGES
GONAL-F RFF 75 UNIT VIAL
The following indications for GONAL-F RFF (follitropin alfa, recomb) have been approved by the FDA:
Indications:
Follicle stimulation for assisted fertilization procedure
Hypogonadotropic hypogonadism
Infertility associated with anovulation
Professional Synonyms:
Infertility associated with ovulation failure
Multifollicular development for assisted reproductive technologies
Indications:
Follicle stimulation for assisted fertilization procedure
Hypogonadotropic hypogonadism
Infertility associated with anovulation
Professional Synonyms:
Infertility associated with ovulation failure
Multifollicular development for assisted reproductive technologies
The following dosing information is available for GONAL-F RFF (follitropin alfa, recomb):
Store multiple-dose vials refrigerated between 2-8degreesC or at room temperature between 20-25degreesC and protect from light. Instruct patients to use the accompanying syringes to administer their dose. The 27-gauge syringe has unit markings from 37.5-600
international units (IU) of follicle-stimulating hormone. Instruct patients to take a specific dose and show them how to locate the marking on the syringe that corresponds with the appropriate dose. The dose should be administered subcutaneously in the abdomen, upper arm, or upper leg.
Each multiple-dose vial delivers either 450 IU or 1050 IU of follicle-stimulating hormone. To reconstitute the 450 IU vial, dissolve the contents of the vial with 1 mL of bacteriostatic water for injection (0.9% benzyl alcohol), USP; the resulting concentration will be 600 IU/mL. The final reconstituted product will deliver the equivalent of 6 doses, with each dose being 75 IU.
To reconstitute the 1050 IU vial, dissolve the contents of the vial with 2 mL of bacteriostatic water for injection (0.9% benzyl alcohol), USP; the resulting concentration will be 600 IU/mL. The final reconstituted product will deliver the equivalent of 14 doses, with each dose being 75 IU. After reconstitution, store solution between 2-8degreesC or at room temperature between 20-25degreesC and protect from light; discard any unused solution after 28 days.
Regardless of indication, the dosing scheme should be stepwise and individualized for each patient.
international units (IU) of follicle-stimulating hormone. Instruct patients to take a specific dose and show them how to locate the marking on the syringe that corresponds with the appropriate dose. The dose should be administered subcutaneously in the abdomen, upper arm, or upper leg.
Each multiple-dose vial delivers either 450 IU or 1050 IU of follicle-stimulating hormone. To reconstitute the 450 IU vial, dissolve the contents of the vial with 1 mL of bacteriostatic water for injection (0.9% benzyl alcohol), USP; the resulting concentration will be 600 IU/mL. The final reconstituted product will deliver the equivalent of 6 doses, with each dose being 75 IU.
To reconstitute the 1050 IU vial, dissolve the contents of the vial with 2 mL of bacteriostatic water for injection (0.9% benzyl alcohol), USP; the resulting concentration will be 600 IU/mL. The final reconstituted product will deliver the equivalent of 14 doses, with each dose being 75 IU. After reconstitution, store solution between 2-8degreesC or at room temperature between 20-25degreesC and protect from light; discard any unused solution after 28 days.
Regardless of indication, the dosing scheme should be stepwise and individualized for each patient.
Follitropin is administered by subcutaneous injection. Follitropin is commercially available in various dosage forms for subcutaneous administration, including multiple-dose vials containing follitropin alfa as lyophilized powder (Gonal-F(R)), single-use prefilled pens containing follitropin alfa (Gonal-F(R) RFF Redi-ject(R) pen), and single-use prefilled cartridges containing follitropin beta (Follistim(R) AQ). If a dose of follitropin is missed, do not double the next dose.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for GONAL-F RFF (follitropin alfa, recomb):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for GONAL-F RFF (follitropin alfa, recomb):
Drug contraindication overview.
*Hypersensitivity to recombinant follicle-stimulating hormone products and/or one of their excipients *Hypersensitivity reactions to streptomycin or neomycin (follitropin beta only since Follistim(R) AQ may contain traces of these antibiotics) *High levels of follicle-stimulating hormone indicative of primary gonadal failure *Uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) *Sex hormone-dependent tumors of the reproductive tract and accessory organs *Tumors of the pituitary gland or hypothalamus *Pregnancy (follitropin beta only) *Abnormal uterine bleeding (follitropin alfa products) or heavy or irregular vaginal bleeding (follitropin beta) with undetermined source *Ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome
*Hypersensitivity to recombinant follicle-stimulating hormone products and/or one of their excipients *Hypersensitivity reactions to streptomycin or neomycin (follitropin beta only since Follistim(R) AQ may contain traces of these antibiotics) *High levels of follicle-stimulating hormone indicative of primary gonadal failure *Uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) *Sex hormone-dependent tumors of the reproductive tract and accessory organs *Tumors of the pituitary gland or hypothalamus *Pregnancy (follitropin beta only) *Abnormal uterine bleeding (follitropin alfa products) or heavy or irregular vaginal bleeding (follitropin beta) with undetermined source *Ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome
There are 8 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Estrogen-dependent neoplasm |
| Hormone receptor positive breast cancer |
| Malignant neoplasm of the ovary |
| Malignant neoplasm of the uterus |
| Malignant tumor of testis |
| Pituitary neoplasm |
| Pregnancy |
| Tumor of hypothalamus |
There are 8 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Abnormal uterine bleeding |
| Acute respiratory distress syndrome |
| Adrenocortical insufficiency |
| Pituitary insufficiency |
| Thromboembolic disorder |
| Thrombophilia |
| Torsion of ovary |
| Untreated hypothyroidism |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Morbid obesity |
| Ovarian hyperstimulation syndrome |
The following adverse reaction information is available for GONAL-F RFF (follitropin alfa, recomb):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 15 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Ovarian cyst Ovarian enlargement Ovarian hyperstimulation syndrome |
Hypotension Migraine |
| Rare/Very Rare |
|---|
|
Acute respiratory distress syndrome Anaphylaxis Arterial thrombosis Asthma exacerbation Cerebrovascular accident Dyspnea Hypersensitivity drug reaction Pulmonary thromboembolism Thromboembolic disorder Torsion of ovary |
There are 34 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abdominal distension Abnormal vaginal bleeding Acne vulgaris Acute abdominal pain Diarrhea Flatulence Flu-like symptoms Headache disorder Mastalgia Mood changes Nausea Pelvic pain Pharyngitis Sinusitis Upper respiratory infection |
Anorexia Candidiasis Chest pain Dizziness Drowsy Dysmenorrhea Dyspepsia Dysplasia of cervix Gynecomastia Injection site sequelae Nervousness Palpitations Polydipsia Pruritus of skin Vaginal discharge Vomiting Weight gain |
| Rare/Very Rare |
|---|
|
Facial edema Urticaria |
The following precautions are available for GONAL-F RFF (follitropin alfa, recomb):
Safety, efficacy, and pharmacokinetics of follitropin products have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Follitropin alfa is not indicated for use in pregnant women, and follitropin beta is contraindicated for use in pregnant women. Data from a limited number of exposed pregnancies indicate no adverse reactions of gonadotropins on pregnancy, embryonal or fetal development, parturition, or postnatal development following controlled ovarian stimulation. In animal studies, continuous administration of recombinant human follicle-stimulating hormone (hFSH) during pregnancy resulted in a decreased number of viable fetuses and difficult and prolonged delivery with no teratogenic effect observed.
Follitropin alfa: There are no data on the presence of follitropin in human milk, the effects on the breast-fed infant, or the effects on milk production. Because the secretion of prolactin during lactation can result in inadequate response to ovarian stimulation, advise women not to breastfeed during treatment. Follitropin beta: There are no data on the presence of follitropin in human milk. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for the drug and any potential adverse effects on the breastfed child from the drug or the underlying maternal condition.
Safety, efficacy, and pharmacokinetics of follitropin have not been established in geriatric patients.
The following prioritized warning is available for GONAL-F RFF (follitropin alfa, recomb):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for GONAL-F RFF (follitropin alfa, recomb)'s list of indications:
| Follicle stimulation for assisted fertilization | |
| Z31.83 | Encounter for assisted reproductive fertility procedure cycle |
| Z31.89 | Encounter for other procreative management |
| Z52.81 | Egg (oocyte) donor |
| Z52.810 | Egg (oocyte) donor under age 35, anonymous recipient |
| Z52.811 | Egg (oocyte) donor under age 35, designated recipient |
| Z52.812 | Egg (oocyte) donor age 35 and over, anonymous recipient |
| Z52.813 | Egg (oocyte) donor age 35 and over, designated recipient |
| Z52.819 | Egg (oocyte) donor, unspecified |
| Hypogonadotropic hypogonadism | |
| E23.0 | Hypopituitarism |
| Infertility associated with anovulation | |
| N97.0 | Female infertility associated with anovulation |
Formulary Reference Tool